Active Pharmaceutical Ingredient Watch

22 April 2002 00:00  [Source: ICB Americas]

ANDRX Corp. reports Biovail Corp. has formerly withdrawn its '463 Orange Book patent for hypertension and angina drug Tiazac (diltiazem) and has agreed to dismiss related patent infringement claims, eliminating a 30-month statutory stay on a generic Tiazac drug approval. Andrx, in discussions with the FDA over dosage strengths of its Taztia XT product, expects a 2002 launch. Andrx has submitted a new drug application in the European Union for Altocor (lovastatin), a lipid lowering agent used in the treatment of elevated cholesterol.

BIOVAIL Corp. has made a á$74 million ($65 million) investment to acquire a 15 percent minority stake in European-based Ethypharm and has signed a á69 million drug development deal, which includes Ethypharm's 5-FU (5 Fluouracil) microspheres to treat glioblastoma. A US commercial launch is expected in 2005.

GENZYME General, a division of Genzyme Corp., posted first quarter underlying net income of $46 million, versus $56 million in the year-ago period, on revenues of $242 million, up 9 percent. Results reflect the reduction of wholesaler inventories of Renagel (sevelamer hydrochloride) and expansion of Renagel manufacturing capacity. Genzyme General and BioMarin Pharmaceutical Inc. have filed the first portion of a rolling biologics license application with the FDA for Aldurazyme (laronidase), an enzyme replacement therapy.

GLAXOSMITHKLINE PLC has agreed to codevelop and commercialize postoperative ileus drug alvimopan (formerly known as ADL8-2698) with Adolor Corp. for step payments totaling $270 million. GSK and Unigene Laboratories Inc. inked a $150 million licensing agreement to develop an oral formulation of an analog of parathyroid hormone to treat osteoporosis.

NOVARTIS has received approval from Swiss regulatory authorities for Glivec (imatinib) for treating metastatic gastrointestinal stromal tumors (GISTs). The drug was approved for GIST in the US and received a recommendation for European approval.

For the latest chemical news, data and analysis that directly impacts your business sign up for a free trial to ICIS news - the breaking online news service for the global chemical industry.

Get the facts and analysis behind the headlines from our market leading weekly magazine: sign up to a free trial to ICIS Chemical Business.

Printer Friendly